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510(k) K885254

TARGET READER by V-Tech, Inc. — Product Code JQT

K885254 is an FDA 510(k) premarket notification submitted by V-Tech, Inc. for the device "TARGET READER". The FDA issued a decision of Substantially Equivalent on January 27, 1989. The device falls under product code JQT (Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica), a Class I device regulated under 21 CFR 862.2400. V-Tech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1989
Date Received
December 23, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
Device Class
Class I
Regulation Number
862.2400
Review Panel
CH
Submission Type

Other clearances by V-Tech, Inc.

  • K914303 — TARGET(TM)-HOG (October 11, 1991)
  • K910892 — TARGET(TM) CANNABINOIDS-V TEST (April 3, 1991)
  • K910893 — TARGET(TM) CANNABINOIDS-R TEST (April 3, 1991)
  • K910739 — TARGET AMPHETAMINE/METHAMPHETAMINE-R (READER METH) (March 21, 1991)
  • K910122 — TARGET COCAINE METABOLITE-R (March 19, 1991)
  • K910738 — TARGET AMPHETAMINE/METHAMPHETAMINE-V (VISUAL METH) (March 19, 1991)
  • K910123 — TARGET COCAINE METABOLITE-V (March 19, 1991)
  • K903937 — TARGET(TM) HOG ONE STEP (October 22, 1990)
  • K890978 — TARGET OPIATES-R (November 17, 1989)
  • K890979 — TARGET OPIATES-V (October 4, 1989)

Other clearances for product code JQT

  • K111356 — ASIMANAGER - AT (November 9, 2011)
  • K944185 — ISOSCAN (November 17, 1994)
  • K915332 — MODEL 795 FLUOROMETER/DENSITOMETER (February 18, 1992)
  • K860645 — ELECTROPHORESIS DATA CENTER (EDC) (December 17, 1986)
  • K862956 — ICON READER (August 19, 1986)
  • K853734 — APOLLO DENSITOMETER (September 25, 1985)
  • K851154 — ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18 (May 13, 1985)
  • K850617 — CORNING 780 FLUOROMETER/DENSITOMETER (March 12, 1985)
  • K850260 — GLEMAN ACD-2020 AUTOMATIC COMPUTING DENSITOMETER (February 27, 1985)
  • K842313 — ELVI 146 SEROSCAN (September 10, 1984)

FDA data resources